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Mallinckrodt halts generics spinoff plans; Allergan Q2 profit down; Regeneron up

Top news

* Mallinckrodt PLC said it is suspending plans to spin off its specialty generics and active pharmaceutical ingredients business, citing uncertainties around the opioid litigation against the company. Mallinckrodt is among the drugmakers facing litigation in the U.S. for allegedly engaging in marketing practices that contributed to the ongoing opioid epidemic.

The company also cited current market conditions as a reason for the suspension and said it is considering a "range of options" that would lead to the separation of the specialty generics business.

* Allergan PLC said its second-quarter non-GAAP net income attributable to shareholders was $1.44 billion, or $4.38 per share, down from $1.51 billion, or $4.42 per share, a year earlier. Revenues for the quarter totaled $4.10 billion, down 0.8% from $4.12 billion in the year-ago period.

Allergan, which is being acquired by AbbVie Inc. in an $84.2 billion deal, raised its GAAP revenue guidance for 2019. The company now expects between $15.43 billion and $15.63 billion for the full year, up from previous guidance of $15.13 billion to $15.43 billion. The company maintained its non-GAAP net income outlook of above $16.55 per share for the full year.

* Regeneron Pharmaceuticals Inc. said its second-quarter 2019 non-GAAP net income was $690 million, or $6.02 per share, up 11% from $624 million, or $5.45 per share, a year earlier. Total revenue for the three-month period was $1.93 billion, up 20% from $1.61 billion in the year-ago period.

* Sanofi and Regeneron said the European Commission approved Dupixent for treating moderate to severe atopic dermatitis — a common chronic inflammatory skin disease — in adolescents who are candidates for systemic therapy. Dupixent, or dupilumab, is the first biologic medicine approved in the EU to treat these patients.

Meanwhile, Dupixent also helped improve severe atopic dermatitis symptoms in children 6 to 11 years old, meeting the main goal of a late-stage study. The phase 3 trial evaluated the safety and efficacy of Dupixent when added to standard-of-care topical corticosteroids for treating severe atopic dermatitis in the children, compared to topical corticosteroids alone.

On the policy front

* Uganda has commenced the country's largest-ever trial of a vaccine for Ebola as it prepares for a potential spillover of the lethal disease from the contiguous Democratic Republic of Congo, Reuters reported, citing a Ugandan official. The World Health Organization previously declared the Ebola crisis in the Democratic Republic of Congo a public health emergency of international concern.

* The U.S. Centers for Disease Control and Prevention reported eight cases of measles in the country for the week ended Aug. 1, bumping up the number of individual cases of measles year-to-date to 1,172 — the highest since 1992. Measles was declared eliminated in the U.S. in 2000.

Drug and product pipeline

* Eli Lilly and Co. said Emgality met its main goal of reducing monthly headaches by 4.1 days among chronic and episodic migraine patients in a late-stage study. The phase 3 trial, dubbed Conquer, evaluated the safety and efficacy of Emgality as a preventive treatment of migraine in 462 patients — 193 with chronic migraine, while 269 had episodic migraine — with documented prior failures on two to four different standard therapy in migraine prevention due to inadequate effectiveness or for safety and tolerability reasons.

* AbbVie Inc. filed for U.S. Food and Drug Administration approval of its women's health drug elagolix to treat heavy menstrual bleeding in women with uterine fibroids. Elagolix, or Orilissa, was submitted to the U.S. regulator based on data from an 800-patient phase 3 clinical trial program under which premenopausal women with uterine fibroids saw less bleeding when taking the therapy.

AbbVie is racing to market with elagolix against a number of similar products under development. Myovant Sciences Ltd. announced in July that the company's similar treatment, relugolix, reduced heavy menstrual bleeding in women with a single-pill treatment regimen. ObsEva SA also has a GnRH antagonist called linzagolix underway for uterine fibroids.

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* Shares of Allakos Inc. jumped by over 100% as the company reported that its digestive disorder treatment AK002 reduced inflammation in a mid-stage study, meeting its primary goal. AK002 was evaluated in a four-month phase 2 study that included 65 patients with eosinophilic gastritis or eosinophilic gastroenteritis, which are severe inflammatory conditions of the stomach or small intestine.

No U.S. FDA-approved treatments exist for these conditions, which can cause abdominal pain, nausea, loss of appetite, bloating and diarrhea.

* Intra-Cellular Therapies Inc. said the FDA has agreed to let the company submit additional information regarding its new drug application for lumateperone to treat schizophrenia. The FDA classified the planned submission as a major amendment to the application and extended the review period by three months, which means the U.S. regulator is expected to make a decision by Dec. 27.

* Basilea Pharmaceuticals Ltd said its antibiotic ceftobiprole was shown to be as effective as vancomycin plus aztreonam in treating patients with acute bacterial skin and skin structure infections — meeting the main goal of a late-stage study called Target. The Swiss drugmaker plans to seek U.S. FDA approval for the drug another study evaluating ceftobiprole in patients with Staphylococcus aureus bloodstream infections yields positive results.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng dropped 0.67% to 25,976.24, while the Nikkei 225 shed 0.65 % to 20,585.31.

In Europe, around midday, the FTSE 100 rose 0.02% to 7,224.90, and the Euronext 100 gained 0.67% to 1,032.69.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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